Company ยท US
Heartport, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1996 to 2000. Name variants (Inc, Corp, punctuation) are merged.
24510(k) clearances (0 in 12 months)
6recalls (0 in 12 months)
6recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 16 |
| DXC | Clamp, Vascular | 5 |
| DRC | Trocar | 2 |
| DWZ | Device, Biopsy, Endomyocardial | 2 |
| DSS | Clip, Vascular | 1 |
| DYB | Introducer, Catheter | 1 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 |
| OCL | Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 5, 2000 | K994243 | DIRECTFLOW KIT, 24 FR, SOFTCLAMP KIT, 24FR, STRAIGHTSHOT KIT, 23 FR, STRAIGHT TIP, STRAIGHTSHOT KIT, 23 FR, ANGLED TIP Heartport, Inc. | DWF |
| Apr 20, 1999 | K981995 | QUICKDRAW VENOUS CANNULA Heartport, Inc. | DWF |
| Mar 23, 1999 | K990772 | DIRECTFLOW ARTERIAL CANNULA Heartport, Inc. | DWF |
| Sep 4, 1998 | K981009 | HEARTPORT ENDOPULMONARY VENT CATHETER Heartport, Inc. | DWF |
| Jul 15, 1998 | K974736 | HEARTPORT DIRECT AORTIC RETURN CANNULA WITH INTRODUCER Heartport, Inc. | DWF |
| Dec 16, 1997 | K974175 | HEARTPORT ENDOAORTIC CLAMP CATHETER Heartport, Inc. | DWZ |
| Oct 1, 1997 | K972570 | HEARTPORT INTRODUCER SHEATH Heartport, Inc. | DYB |
| Jun 17, 1997 | K971291 | HEARTPORT ENDOARTERIAL RETURN CANNULA Heartport, Inc. | DWF |
| May 9, 1997 | K970496 | HEARTPORT MAZE SYSTEM: CRYOPROBE SET Heartport, Inc. | OCL |
| May 9, 1997 | K964302 | HEARTPORT THORACIC TROCAR Heartport, Inc. | DRC |
| Apr 4, 1997 | K964161 | HEARTPORT ENDOAORTIC CLAMP Heartport, Inc. | DXC |
| Mar 12, 1997 | K965051 | HEARTPORT NEEDLE TROCAR Heartport, Inc. | DRC |
| Feb 10, 1997 | K962835 | HEARTPORT ENDOVENOUS DRAINAGE CANNULA Heartport, Inc. | DWF |
| Jan 22, 1997 | K964248 | HEARTPORT ENDOCORONARY SINUS CATHETR Heartport, Inc. | DWF |
| Nov 15, 1996 | K961334 | HEARTPORT HANDSWITCH ELECTROCAUTERY PROBE Heartport, Inc. | GEI |
| Nov 15, 1996 | K961333 | HEARTPORT MULTIFIRE CLIP APPLIER Heartport, Inc. | DSS |
| Nov 7, 1996 | K962366 | HEARTPORT CABLE BULLDOG CLAMP Heartport, Inc. | DXC |
| Oct 8, 1996 | K961463 | HEARTPORT THORACIC SURGICAL TROCARS: (TOST-4-3, TOSTL-6-3, TON-4-2 AND TONL-6-2 Heartport, Inc. | GCJ |
| Sep 30, 1996 | K962858 | HEARTPORT ENDOVASCULAR CARDIOPULMONARY BYPASS SYSTEM ANTEGRADE SYTEM (CATALOG NUMBER ECPB-A) ANTEGRADE/RETROGRADE SYSTEM Heartport, Inc. | DXC |
| Sep 11, 1996 | K962510 | HEARTPORT ENDOAORTIC CLAMP Heartport, Inc. | DXC |
| Jun 18, 1996 | K961270 | HEARTPORT ENDOSINUS CATHETER Heartport, Inc. | DWF |
| Jun 18, 1996 | K961245 | HEARTPORT ENDOPULMONARY VENT Heartport, Inc. | DWF |
| Jun 7, 1996 | K955132 | HEARTPORT ENDOAORTIC CLAMP Heartport, Inc. | DXC |
| May 10, 1996 | K955121 | HEARTPORT ENDOARTERIAL RETURN CANNUAL Heartport, Inc. | DWF |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 10, 2005 | Heartport, Inc. The Heartport EndoClamp aortic catheter is a 10.5 Fr. wirewound, three-lumen catheter with an elastomeric balloon near its tip. This device is used with a 200 cm j-hook guide wire accessory device. Terminated |
DWZ | K974175 |
| Jan 9, 2004 | Heartport Inc Introducer Sheath is indicated for patients requiring introduction of catheters. Introducer Sheath for EndoClamp, aortic catheter, 19Fr. IS19 (07042). Terminated |
DWF | K955121 K971291 +4 |
| Jan 9, 2004 | Heartport Inc SoftClamp II arterial cannula is intended to deliver oxygenated blood for cardiopulmonary bypass during surgery. The product also allows the hemostatic introduction and removal of the Heartport EndoC Terminated |
DWF | K955121 K971291 +4 |
| Jan 9, 2004 | Heartport Inc DirectFlow arterial cannula is intended to deliver oxygenated blood for cardiopulmonary bypass during surgery. The product also allows the hemostatic introduction and removal of the Heartport EndoCla Terminated |
DWF | K955121 K971291 +4 |
| Jan 9, 2004 | Heartport Inc EndoReturn arterial cannula. The EndoReturn arterial cannula is indicated for patients undergoing cardiopulmonary bypass. The EndoReturn cannula with hemostasis valve allows for hemostatic introduct Terminated |
DWF | K955121 K971291 +4 |
| Jan 9, 2004 | Heartport Inc EndoReturn arterial cannula. The EndoReturn arterial cannula is indicated for patients undergoing cardiopulmonary bypass. The EndoReturn cannula with hemostasis valve allows for hemostatic introduct Terminated |
DWF | K955121 K971291 +4 |